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The Sponsor is doing a research study to assess the effects of a smartphone program designed to help users smoke less and eventually quit. When participants join, their involvement in the core study will last 8 weeks. After 8 weeks, they will have the option to continue using the program to guide their quit journey or participate in follow-up research.
The overarching study aim is to recruit and enroll a population of current smokers who are motivated to quit with the assistance of a mobile solution.
The core study period will consist of 8 weeks of iPhone program usage. Comprehensive questionnaires will be given to the user during the course of their application usage. Users will receive notifications to link them to these online surveys, which will record their responses in a secure database. Following the 8-week core study, participants may continue usage of the program.
During the course of their use of the program, participants will be asked to provide information regarding three general areas on a regular basis as part of their use of the app: smoking status, adherence to self or physician-directed quit plans (including but not limited to medications for smoking cessation and over-the-counter quit aids), and overall user satisfaction. One way that the program assesses these areas involves asking users to answer questions addressing whether or not the user used nicotine in the last 24 hours. At the end of each week, users will also be asked to report their cigarette count for each of the past 7 days, using the standardized reporting technique called the Timeline Followback (TLFB) Method Assessment (Sobell, 1992).
At the 16-week mark and at the 24-week mark after enrollment, users will receive a brief questionnaire retrospectively looking at their cigarette usage, adherence to quit aids, and physical symptoms of nicotine withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Smoking Cessation Solution | Experimental | Subjects download & use the mobile application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Smoking Cessation Solution | Device | The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Remain Active Users of the Program | The primary objective is to assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8 week primary study period. Active use is defined as the manipulation of at least one component of the application per week. | 8 week core study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | To evaluate the tolerability and safety of the application | 8 week core study |
| Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] |
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Inclusion Criteria:
Exclusion Criteria:
Unable or unwilling to provide informed consent
Responds appropriately to any item in the Eligibility Questionnaire:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Schork, PhD | J. Craig Venter Institute | Principal Investigator |
| Ted Silver | Click Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28442453 | Derived | Iacoviello BM, Steinerman JR, Klein DB, Silver TL, Berger AG, Luo SX, Schork NJ. Clickotine, A Personalized Smartphone App for Smoking Cessation: Initial Evaluation. JMIR Mhealth Uhealth. 2017 Apr 25;5(4):e56. doi: 10.2196/mhealth.7226. |
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All participants that completed informed consent, baseline survey, and downloaded the app were included in the single arm ITT sample.
We recruited potential participants from May to July 2016. Digital advertisements were posted to social media outlets targeting users who searched for "quit smoking". The study team contacted respondents by telephone to prescreen for eligibility and, if appropriate, directed them to a Web portal for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mobile Smoking Cessation Solution | Subjects download & use the mobile application. Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mobile Smoking Cessation Solution | Subjects download & use the mobile application. Mobile Smoking Cessation Solution: The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete "missions", daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly "Check-Ins" are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Remain Active Users of the Program | The primary objective is to assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8 week primary study period. Active use is defined as the manipulation of at least one component of the application per week. | 416 participants ultimately downloaded the app and constituted the ITT population. | Posted | Count of Participants | Participants | 8 week core study |
|
4 months
Negative health events were ascertained via spontaneous report by users in-app and via proactive ascertainment by a focused question in the week-8 questionnaire. All negative health events reported were sent to the medical monitor for evaluation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events | Total Adverse Events | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Scientific Affairs | Click Therapeutics | 646-844-2158 | brian@clicktherapeutics.com |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D019966 | Substance-Related Disorders |
| D012907 | Smoking |
| D000073865 | Cigarette Smoking |
| D000073869 | Tobacco Smoking |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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|
To assess whether continued user engagement is correlated with smoking cessation and behaviors.
| 8 week core study |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Treatment-related Adverse Events | To evaluate the tolerability and safety of the application | 416 participants ultimately downloaded the app and constituted the ITT population. | Posted | Number | Participants | 8 week core study |
|
|
|
| Secondary | Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence] | To assess whether continued user engagement is correlated with smoking cessation and behaviors. | ITT sample included all subjects who consented to participation, fulfilled study entry criteria, completed the Introductory Questionnaire to receive the access code, and downloaded Clickotine®, and create a user profile. Completer sample included all ITT participants that also completed the outcome survey. | Posted | Count of Participants | Participants | 8 week core study |
|
|
|
| 416 |
| 0 |
| 416 |
| 19 |
| 416 |
| Mood Change | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nightmare | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pharyngitis | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Decreased Mobility | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Silent Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hand Repair Operation | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
|
| Dental Discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Kidney Infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Emergency Care | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Sciatica | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hernia Obstructive | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
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| D003192 |
| Compulsive Behavior |
| D007175 | Impulsive Behavior |